• Amarin Corp. plc, of London, said the FDA indicated that an additional Phase III trial demonstrating robust results, in conjunction with confirmatory evidence from the existing clinical data, might be sufficient to support a new drug application for Miraxion in Huntington's disease. The company now is determining the design for the Phase III trial and is deciding whether to move forward on its own or seek a partner to defray costs. Amarin previously conducted two Phase III studies of Miraxion in HD patients, both of which missed their primary and secondary endpoints, though the drug showed efficacy in a subset of patients. Further analysis of those data indicated that a clinical benefit could be seen from a longer treatment period with Miraxion. The news sent Amarin's shares (NASDAQ:AMRN) up 45.2 percent, or 13 cents, Monday to close at 43 cents. (See BioWorld Today, April 25, 2007.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., has signed a license agreement with Medical Aesthetics Technology Corp., covering the use of its calcium phosphate nanotechnology as a facial filler in aesthetic medicine. The license is a result of a previous option agreement between the two companies. Under the agreement, MATC is responsible for continued development, including required clinical trials, regulatory filings and all manufacturing and marketing of the product.

• Ceragenix Pharmaceuticals Inc., of Denver, has entered into an exclusive distribution and supply agreement with Dr. Reddy's Laboratories Inc., of Hyderabad, India, to commercialize EpiCeram, a prescription topical cream for treating atopic dermatitis and other dry skin conditions, in the U.S. The agreement grants Dr. Reddy's exclusivity in the U.S. for distributing and marketing EpiCeram while Ceragenix will be responsible for manufacturing and supply. Ceragenix will receive undisclosed milestone payments and, upon commercialization, royalty payments based on net sales.

• Cook Pharmica, of Bloomington, Ind., the contract biopharmaceutical manufacturing and development services arm of Cook Medical, signed an agreement with Laguna Niguel, Calif.-based Inspiration Biopharmaceuticals, to conduct development work on its lead biologic therapy, an intravenous Factor IX product for hemophilia B. Financial terms were not disclosed.

• Emergent BioSolutions Inc., of Rockville, Md., said the Department of Health and Human Services reaffirmed its commitment to continue purchasing BioThrax (anthrax vaccine absorbed) under the current contract for 18.75 million doses for a fixed price of $400 million, plus an additional $34 million upon receipt of regulatory approval of four year dating. Emergent signed the three-year contract in September to supply anthrax vaccine to the biodefense stockpile. (See BioWorld Today, Sept. 27, 2007.)

• Genelabs Technologies Inc., of Redwood City, Calif., said it has regained full development and licensing rights in Japan for its investigational lupus drug Prestara (GL701), under the terms of a termination agreement between the company and Mitsubishi Tanabe Pharma Corp., of Osaka, Japan. That 2004 agreement made Tanabe responsible for all development work and obtaining regulatory approval for Prestara in Japan. Under the terms of the agreement, Genelabs received an initial $2 million nonrefundable license fee. In addition, $10 million of milestone payments were to be made on the achievement of pre-determined development goals, but no additional milestone payments were received. Mitsubishi Tanabe continues to own common stock in the company, which they purchased for $2.6 million as part of the 2004 agreement. No payments are to be made by either party as a result of the termination. Mitsubishi Tanabe Pharma was formed Oct. 1 by the merger of Tanabe Seiyaku Co. Ltd. and Mitsubishi Pharma Corp.

• Genta Inc., of Berkeley Heights, N.J., received a letter from Nasdaq, stating that the company is not in compliance with the minimum $10 million value in stockholder's equity requirement needed for continued listing. Genta said it intends to provide a plan to Nasdaq staff to resume compliance on or before Nov. 27, 2007.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, said its drug candidate, Triolex (HE3286) provided benefit in an animal model of collagen antibody-induced arthritis (CAIA). Data demonstrated that Triolex treatment significantly reduced disease in the murine model of CAIA in a dose-dependent fashion, with the highest dose completing eliminating disease, and that the drug was effective regardless of whether treatment began one day or five days after animals were injected with arthrogenic antibodies to induce disease. Those results were presented at the immunology conference in Chicago.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, completed its sale of substantially all of its research and development assets to Biolipox AB, of Stockholm, Sweden. Inflazyme received $4 million in cash for the sale of its PDE inhibitors, its LSAIDs and its protein therapeutic technology. The company also might receive up to $7 million in potential milestones, plus royalty payments, including: $1.5 million upon a decision to enter Phase IIb testing with a PDE inhibitor; $2.5 million upon a decision to begin a Phase III study with a PDE inhibitor; $3 million upon starting a Phase III study with an LSAID; and a modest royalty of 1.25 percent on net sales of the first PDE inhibitor commercialized. Inflazyme also might receive up to 35 percent of the proceeds from the subsequent sale of the protein therapeutic technology if those assets are sold within 12 months of the transaction's closing.

• Kiadis Pharma BV, of Amsterdam, the Netherlands, agreed to provide Rhitol during a limited period of time to requesting physicians participating in the ongoing Phase I/II trial, which closed for enrollment and is expected to finish at the end of this year. Rhitol is in development for severe, chronic, steroid-refractory graft-vs.-host disease patients who have exhausted other treatment options. Kiadis anticipates beginning a Phase III study in 2008.

• Maxygen Inc., of Redwood City, Calif., expects to recognize about $7 million in fourth-quarter revenue under the terms of its license agreement with Codexis Inc., also of Redwood City. That payment reflects the expanded collaboration agreement between Royal Dutch Shell plc, of the Hague, the Netherlands, and Codexis, a 2003 Maxygen spinout, for the development of new superenzymes to convert biomass to fuel. Shell also made an equity investment in Codexis, which reduces Maxygen's ownership in Codexis to about 25 percent.

• Meyer Pharmaceuticals LLC, of Irvine, Calif., licensed a drug technology for treating inflammatory conditions such as arthritis and skin disease from Osaka, Japan-based AnGes MG Inc. The drug, an oligonucleotide designed specifically to block NF-kB, a transcription factor that activates pro-inflammatory genes, currently is in Phase II testing in atopic dermatitis. The deal gives Meyer exclusive development and marketing rights for the NF-kB decoy in treating diseases, such as dermatitis, orthopedic diseases, airway diseases and inflammatory bowel disease, in North America and Europe, while AnGes retains co-promotion rights in the European Union. AnGes will continue developing the product in Japan. Financial terms were not disclosed.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., said the California District Court issued a favorable ruling in the company's intellectual property rights litigation with Nofil Corp., with regard to the Microcyn Technology. In 2006, Oculus filed a lawsuit against Nofil, alleging the company and its CEO Naoshi Kono committed breach of contract, misappropriation of trade secrets and trademark violation. The court sided with Oculus and issued a permanent injunction preventing Nofil from using the intellectual properties of Oculus. Nofil also was banned from manufacturing products with the Microcyn Technology, and the court ruling called for accounting and payment of previous Nofil profits to Oculus.

• Ondine Biopharma Corp., of Vancouver, British Columbia, said it successfully concluded a preclinical program demonstrating high efficacy of its Photodisinfection technology against cultures and biofilms of Pseudomonas aeruginosa. The company's photodisinfection technology proven highly effective at disrupting Pseudomonas biofilms and rapidly killing the bacteria in vitro. The eradication process does not upregulate bacterial resistance factors because the process is rapid, the kill rates are high, and killing occurs through disruption of surface membranes rather than internal metabolic processes, the company said.

• Photocure ASA, of Oslo, Norway, said its board decided to de-merge PCI Biotech, its cancer-focused drug delivery subsidiary. PCI, which develops a method for light-directed drug delivery of therapeutic molecules directly into tumor cells, intends to seek a public listing on the Oslo Stock Exchange following completion of the de-merger process.

• Point Therapeutics Inc., of Wellesley, Mass., received an additional notice of noncompliance from Nasdaq, stating that the company no longer satisfies the stockholders' equity requirement of $2.5 million for continued listing. The company received notice in September that its stock had fallen below the $1 minimum share price needed for continued listing. Point, which agreed last month to merge with Raleigh, N.C.-based Dara BioSciences Inc., has said that all listing requirements will be satisfied upon completion of the merger. (See BioWorld Today, Oct. 11, 2007.)

• Schering-Plough Corp., of Kenilworth, N.J., completed its acquisition of Organon BioSciences NV, of Oss, the Netherlands, a firm comprised primarily of human health business Organon and animal health business Intervet. It also includes Nobilon, a human vaccine development unit and Diosynth, a third-party manufacturing unit. Schering-Plough agreed to buy Organon BioSciences in March from Azko Nobel NV, of Amsterdam, the Netherlands, for about €11 billion (US$16.1 billion) in cash.

• Sciele Pharma Inc., of Boston, has signed an exclusive agreement with Novo Nordisk Inc., of Bagsvaerd, Denmark, to market Prandin, an oral glucose-lowering treatment used to manage Type II diabetes. Sciele will exclusively market Prandin and potentially, PrandiMet, upon FDA approval, to physicians in the U.S. Sciele also will have 'the right of first refusal for marketing rights in the U.S. to other Novo Nordisk products containing repaglinide,' the company said, which is the active ingredient in both Prandin and PrandiMet. Specific terms of the agreement were not disclosed.

• The Medicines Co., of Parsippany, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion to extend the indication for Angiox (bivalirudin) to adult patients with acute coronary syndromes planned for urgent or early intervention, specifically patients with unstable angina or non-ST segment elevation myocardial infarction. The European Commission, expected to make a decision on the application in the first quarter of 2008, usually follows the CHMP's recommendation. Angiox previously was approved for use as an anticoagulant in patients undergoing percutaneous coronary interventions.